NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00, Independent Basic Experimental Studies with Humans Required)

NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00, Independent Basic Experimental Studies with Humans Required)

Historical status

PAR-23-288 is closed and should be read as an archive entry, not as an open call. The official NIH Guide page labels the notice expired. Its final listed application deadline was June 15, 2026, while the page also gives an expiration date of May 25, 2026 under the NIH implementation notice for changes to basic experimental studies involving humans. Because the notice is expired and no new PAR-23-288 cycle has been announced, this page keeps the final real deadline in its metadata and sets historicalReference = true.

The change is more than an ordinary missed deadline. NIH announced that basic experimental studies involving humans, commonly called BESH, would no longer be treated as clinical trials for applications submitted on or after May 25, 2026. NIH also said that BESH-specific notices would be retired because this work could be accepted through Clinical Trials Not Allowed companion notices. NCI’s current K99/R00 guidance directs applicants to PAR-25-135 or PAR-25-313, depending on whether the proposed work is a clinical-trial-not-allowed project or a clinical-trial-required project. Those current notices are the proper starting point for a new application; this archived page describes what PAR-23-288 was designed to support.

At a glance

What the historical notice funded

The purpose of this K99/R00 mechanism was to help a talented postdoctoral researcher complete a defined period of mentored training and then move into an independent research position. It was not a general postdoctoral fellowship and it was not a small project grant. The application needed to show a credible scientific and career transition: what the candidate still needed to learn during the K99 phase, how that work would prepare an independent program, and why the R00 phase was a natural continuation rather than a second unrelated project.

PAR-23-288 was the NCI notice for candidates proposing to lead an independent clinical trial, clinical-trial feasibility study, or separate ancillary clinical trial when the study also met the notice’s definition of basic research. The science had to involve prospective assignment of human participants to conditions or interventions and assessment of biomedical or behavioral outcomes for the purpose of understanding fundamental phenomena without a specific application toward a product, procedure, or service in mind. That distinction mattered. A study with an immediate therapeutic, safety, efficacy, or other direct clinical application belonged in a different clinical-trial-required route. An observational project, or a project in which the candidate only gained experience on a trial led by someone else, belonged in the clinical-trial-not-allowed companion route.

The notice particularly encouraged research relevant to NCI’s mission, including cancer control, cancer prevention, cancer data sciences, cancer biology, population sciences, survivorship, and outcomes research. Mission fit was not satisfied by adding a cancer keyword to an otherwise unrelated proposal. The research question, candidate’s training plan, mentor support, and intended independent program all needed to make sense for NCI.

Award amount and duration

The award had two linked phases. The K99 phase could provide up to two years of mentored postdoctoral research training and career development. The R00 phase could provide up to three years of independent research support, for a maximum project period of five years. Moving to R00 was contingent on satisfactory K99 progress and on accepting an appropriate independent tenure-track or equivalent faculty position. The transition was intended to be continuous, and an R00 award was not automatic merely because the candidate had received a K99.

For the extramural K99 phase, NCI could contribute up to $100,000 per year toward the candidate’s salary, subject to the institution’s salary structure and the notice’s requirements. NCI could also contribute up to $30,000 per year toward research development costs. The latter category could cover items such as career-development tuition and fees, research supplies and equipment, technical personnel, travel for research meetings or training, and statistical services. Mentor salary and secretarial or administrative assistant salary were not allowable under the stated ancillary personnel restrictions. K99 indirect costs were reimbursed at 8% of modified total direct costs.

For the R00 phase, the total cost could not exceed $249,000 per year. That ceiling included salary, fringe benefits, research costs, and applicable indirect costs. The candidate’s salary also remained subject to the legislated NIH salary cap and the award’s effort rules. These figures describe the historical notice’s budget framework; they are not a promise of an award amount and should not be carried into a new application without checking the current NOFO.

Candidate eligibility in the closed notice

The historical notice targeted early-stage researchers who needed a short, purposeful period of additional mentored development. Candidates needed a research or clinical doctorate and had to be in a mentored postdoctoral training position. The notice set the ordinary eligibility window at no more than two years of postdoctoral research experience as of the relevant application due date. The candidate had to explain why at least one year of additional mentored research and career development was needed before independence. A candidate already working in an independent faculty or other non-mentored research position was not eligible for the K99/R00 award.

Position titles were not decisive by themselves. Some institutions use titles such as instructor, research fellow, staff scientist, or another title for people who remain in supervised postdoctoral training. In those cases, the candidate was responsible for documenting that the appointment was genuinely mentored and non-independent. Conversely, an applicant who had a faculty-equivalent role, independent research space, an independent start-up package, or authority characteristic of an independent investigator could fall outside the program even if the local title still included “postdoctoral.”

There was no citizenship requirement for a K99 candidate. A non-U.S. citizen could apply if the visa allowed the candidate to conduct the proposed work during the K99 phase and, later, during the R00 phase. The applicant organization needed to document that status. Foreign institutions themselves were not eligible applicants for the historical notice, but foreign components of eligible U.S. organizations were allowed. The R00 phase required an eligible U.S. institution with the facilities, research environment, and external funding history needed to support the proposed independent program.

The notice also excluded candidates who had already held an independent research faculty or tenure-track-equivalent position, who had more than the permitted postdoctoral research experience, or who had served as an independent PD/PI on disqualifying research or career-development awards. The candidate and institution were expected to confirm edge cases with NCI before preparing an application. This is especially important for unusual job titles, clinical faculty appointments, part-time research histories, childbirth or other justified eligibility extensions, and candidates whose work was split between research and clinical training.

What a compliant application required

The historical application used the NIH Career Development (K) instructions and the SF424(R&R) application framework. Applications were submitted electronically. The available submission routes included NIH ASSIST, an institutional system-to-system submission to Grants.gov, or Grants.gov Workspace, followed by tracking and final status review in eRA Commons. The applicant organization had to complete the required SAM, UEI, eRA Commons, Grants.gov, and related registrations before submission. A registration problem was not a reason for a late application.

The core application was broader than a research proposal. It included the Candidate section, Research Plan, Other Candidate Information, Mentor/Co-Mentor/Consultant/Collaborators material, Environment and Institutional Commitment to the Candidate, other research-plan sections, and the appendix items permitted by the application guide. The Candidate section needed to connect the applicant’s scientific history, career goals, training gaps, and intended independent program. It also needed a timeline with milestones for evaluating progress in the mentored phase and deciding whether the candidate was ready to transition.

The research plan had to span both phases. It should have identified which aims belonged to K99, which aims belonged to R00, and what evidence would show that the candidate could separate scientifically from the mentor. Because PAR-23-288 covered human basic experimental studies under its former clinical-trial classification, the application also needed the applicable PHS Human Subjects and Clinical Trials Information records. The design, assignment or intervention, outcomes, recruitment, analysis, human-subject protections, and regulatory plan had to agree with one another.

The mentor statement was a substantive part of the submission. It needed to describe the mentor’s qualifications, the supervision and training plan, how the candidate would gain independence, how the work would transition to the R00 phase, and which research components or resources the candidate could take forward. The institutional commitment statement needed to document a strong research environment, facilities, collaborators, protected time, and a real commitment to the candidate’s move toward independence. The K99 phase required at least 75% of the candidate’s full-time professional effort, or 9 person-months, for career development and research activities.

Budget preparation also had phase-specific rules. K99 budget periods required itemized information. For the R00 phase, the application could provide a total request for each period within the $249,000 annual ceiling, with a detailed budget prepared by the R00 institution when the transition was activated. Research generating scientific data required a Data Management and Sharing Plan. Reference letters were submitted through eRA Commons as a separate process, and missing required letters could prevent review.

How to use this page now

Do not submit a new application to PAR-23-288 simply because the archived notice still displays a table of recurring dates. The notice is expired, the final listed deadline has passed, and NIH’s policy change removed the reason for keeping a BESH-specific clinical-trial notice open. Use the current NCI K99/R00 page and read the full current NOFO before choosing a route.

For a new project that is not an independent clinical trial, NCI identifies PAR-25-135, the Clinical Trial Not Allowed notice, as the current route. NIH’s BESH policy says that basic experimental studies involving humans can now be handled through Clinical Trials Not Allowed companions. For a project in which the candidate will lead an independent clinical trial, a clinical-trial feasibility study, or a separate ancillary clinical trial, NCI identifies PAR-25-313, the Clinical Trial Required notice. The correct choice depends on the study’s actual purpose and design, not on the title of the archived page.

Regardless of route, a prospective applicant should first confirm NCI scientific fit and the candidate’s eligibility with the relevant NCI program contact. Next, confirm that the institution’s registrations and internal approvals are current. Then build the candidate-development plan and research plan together, showing the K99 training gap, the R00 independence milestone, the mentor’s boundaries, protected effort, human-subjects protections, data-management responsibilities, and a realistic budget. Finally, submit through the current notice’s electronic process early enough to inspect the application in eRA Commons and correct any system errors before the applicable deadline.

Official sources

• Archived NIH Guide record for PAR-23-288
• Current NCI K99/R00 guidance
• NIH notice on the BESH policy change
• NCI notice discontinuing the prior parent K99/R00 participation
• Current NCI K99/R00 Clinical Trial Not Allowed notice, PAR-25-135
• Current NCI K99/R00 Clinical Trial Required notice, PAR-25-313